Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Summary
The FDA issued a Class II for Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B by Medline Industries, LP. Reason: A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of.
Details
Source
Device Recall
External ID
Z-1313-2026
Action Date
2026-02-18
Status
Ongoing
Category
device
Product Description
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Lot/Code Info: Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Quantity Affected: 130
Reason for Recall
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Distribution
Distribution US nationwide and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-24
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1313-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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